Kornimate/medical-research-clean huggingface dataset:
a phase 1-2 dose-escalation and cohort-expansion study of oral tomivosertib (eft-508) in subjects with hematological malignancies

Conditions: Lymphoma

Summary: this clinical trial is a phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of tomivosertib (eft-508). the study will evaluate oral daily administration of tomivosertib (eft-508). treatment and study subject evaluation will be performed in 21-day cycles.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0 or 1. 2. presence of an active hematological malignancy. 3. presence of measurable disease. 4. hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation. 5. at least 2 weeks post any treatments/therapies at the time of first dose. 6. adequate bone marrow function. 7. adequate hepatic function. 8. adequate renal function. 9. normal coagulation panel. 10. negative antiviral serology. 11. willingness to use effective contraception. exclusion criteria: 1. central nervous system malignancy 2. gastrointestinal disease 3. significant cardiovascular disease 4. significant ecg abnormalities. 5. ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation 6. ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) 7. pregnancy or breastfeeding. 8. major surgery within 4 weeks before the start of study therapy. 9. ongoing immunosuppressive therapy, including systemic or enteric corticosteroids 10. use of drugs that could prolong the qt interval within 7 days before the start of study therapy. 11. use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.

Keywords: small molecule inhibitor of protein translation immunomodulator phase 1 dose escalation
remote alcohol monitoring to facilitate abstinence reinforcement: feasibility

Conditions: Alcohol Use Disorder

Summary: directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. the goal of this feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. if validated, this treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.


Eligibility criteria:
inclusion criteria: * at least 18 years old * provide written informed consent * meet diagnostic and statistical manual criteria for alcohol use disorder * express a desire to cut down or quit drinking exclusion criteria: * pregnant or lactating * meet diagnostic and statistical manual criteria for other substance use disorder (except caffeine or nicotine) * score 23 or greater on the alcohol withdrawal symptom checklist * have immediate plans to move out of the area
preterm infants fed a human milk fortifier

Conditions: Growth

Summary: this is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (hmf).


Eligibility criteria:
inclusion criteria: * birth weight between 700 g-1500 g. * ≤ 32 weeks and 0 days ga at birth. * participant has been classified as appropriate for ga (aga). * enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0) * mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized. * parent(s) agrees to allow infant to receive both human milk and study hmf. * singleton or twin births only. * infant's parent(s) or a lar has voluntarily signed and dated an icf, approved by an irb/iec and provided hipaa (or other applicable privacy regulation) authorization prior to any participation in the study. exclusion criteria: * enteral feeding of preterm infant formula or hmf for \> 7 days. * expected to be transferred to another facility within 30 days of randomization. * serious congenital abnormalities or underlying disease that may affect growth and development. * 5-minute apgar ≤ 4. * receiving systemic steroids at time of randomization. * receiving probiotics at time of randomization. * grade ill or iv pvh/ivh. * dependent on invasive ventilation at time of randomization. * maternal incapacity. * mother or infant is currently receiving treatment consistent with hiv therapy. * documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse. * positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant. * infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia). * asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by apgar score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life. * confirmed nec (bell's stage ii or iii). * confirmed current sepsis. * infant has any other condition that, in the opinion of the investigator, precludes participation in the study. * participation in another study that has not been approved as a concomitant study by an. * participant has an allergy or intolerance to any ingredient in study fortifier.
plantar pain, balance and foot function in individuals with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: diabetes mellitus (dm) and increase of body mass index (bmi) are two one of the most common risk factors for plantar pain and related disability. the aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic dm patients has with different bmi.


Eligibility criteria:
inclusion criteria: * having plantar pain * and no change in bmi by more than 10% for at least 3 months * being volunteer to participate to the study exclusion criteria: * having musculoskeletal surgery for foot * having neurological, orthopedic, and cardiovascular diseases * vision and hearing problems that may cause balance disorder

Keywords: diabetes mellitus plantar pain body mass index obesity balance foot pain disability
functional recovery after medial monocompartmental knee prosthesis: one day protocol versus fast protocol

Conditions: Gonarthrosis

Summary: the study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (group a), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group b).

the study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (group a), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group b). the difference will be evaluated with the knee society scopre (kss) questionnaire at 1 month after the operation. the population is made up of two groups of patients: 25 patients group a: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients group b: fast protocol; control group discharged to the rehabilitation department of the institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard the subjects will undergo the following assessments: * pre-admission * knee replacement surgery * rehabilitation * questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. if necessary, they can be collected by telephone.

Eligibility criteria:
inclusion criteria: * age 40\<x\<85 included * medial monocompartmental gonarthrosis grade 3-4 sec kellgren-lawrence * primary medial gonarthrosis * signing of the informed consent and consent to collaborate in all study procedures. exclusion criteria: * cognitive decline * psychiatric disorders * neuromuscular disorders * age \> 85 years or \<40 * lateral gonarthrosis grade 3-4 sec kellgren-lawrence * patella symptoms * secondary medial gonarthrosis * minor age * pregnant women (self-declaration)

Keywords: gonarthrosis rehabilitation
study of diosmin for the treatment of digital ulcers in systemic sclerosis

Conditions: Scleroderma, Systemic; Digital Ulcer

Summary: this study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). two (2) out of three (3) participants will receive active product. the participants will have four (4) visits over eight (8) weeks. physical exams and photos will be performed. a variety of questions will be asked describing level of pain and lifestyle changes.

this study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). the study will include 21-45 participants randomly given active product or inactive product (placebo). two (2) out of every three (3) participants enrolled will receive active product. the participants will have four (4) visits over eight (8) weeks. at each visit physical exams and photos will be performed. each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis (scleroderma) * at least one "active" digital ulcer * medication for systemic sclerosis unchanged for 30 days exclusion criteria: * infection or gangrene in ulcer * citrus allergy * unstable heart, kidney, or liver disease * active infection of any type * current cancer treatment or uncured cancer * pregnancy or breast feeding

Keywords: ssc digital ulcers sclerosis scleroderma
role of non-specific effects in the treatment of depression with esketamine

Conditions: Depressive Episode

Summary: the investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.

primary objective: to determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment. secondary objectives: to determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment. to determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by madrs score within 24 hours after the first treatment. to determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by madrs score by the end of the acute course of esketamine treatment.

Eligibility criteria:
inclusion criteria: * participants must be either male or female and at least 18 years old * deemed clinically appropriate to receive esketamine by a yale interventional psychiatry physician. * written consent for the study procedures * ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study. exclusion criteria: * hearing or visual impairment to the degree that would interfere with ability to view the presentation * difficulty in understanding spoken or written english * unable to provide informed consent * dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment) * any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. * previous esketamine or ketamine treatment * unable to give informed consent * was previously enrolled/randomized into the trial
immunophenotyping of patients with postoperative sirs

Conditions: Systemic Inflammatory Response Syndrome

Summary: the purpose of this study is to develop an immune-phenotype based prediction of postoperative sirs in patients undergoing open heart surgery.

the study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. the samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. the diagnosis of sirs will be made during routine clinical visits on the first seven postoperative days using the sepsis-related organ failure assessment score (sofa-score). the patients will be followed up for 30 days.

Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent of the patient * patient undergoing a open heart surgery using a cardiopulmonary bypass exclusion criteria: * age \< 18 years * missing informed consent * renal failure * liver failure * neurodegenerative disease * malignancies * immune therapy

Keywords: immunophenotyping perioperative care innate immunity cardiac surgical procedures
a study testing if medicine can make pigment epithelium detachments regress and stabilize the vision in eyes

Conditions: Macular Degeneration; Retinal Detachment

Summary: the purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (ped) in relation to age related maculopathy (amd). patients with newly diagnosed ped without choroidal neovascularisations (cnv), will be randomized to either treatment or observation. the treatment group will first be given injections with anti vascular endothelium growth factor (anti-vegf). if the injections do not have any effect, verteporfin photodynamic therapy (pdt) will be given. all patients will be followed for a period of 2 years. it is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with amd.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 50 years * pigment epithelium detachment in an eye not earlier treated with anti-vegf or verteporfin pdt. * etdrs best corrected visual acuity 20/32 - 20/400 exclusion criteria: * prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, previous subfoveal focal laser photocoagulation involving the foveal center, history of vitrectomy, submacular surgery, or other surgical intervention for amd. * cnv, subfoveal fibrosis or atrophy in study eye. * concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. active intraocular inflammation in the study eye.

Keywords: angiogenesis inhibitors photochemotherapy vascular endothelium growth factors aflibercept
comparison of arterolane-piperaquine versus arterolane-piperaquine+mefloquine versus artemether-lumefantrine in kenyan children

Conditions: Plasmodium Falciparum

Summary: this open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in kilifi, kenya. this study will also provide an up to date insight on the current presence of antimalarial resistance in this site. in addition, all children will be treated with a single low dose of primaquine, dosing is age based. the investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in kilifi county hospital.


Eligibility criteria:
inclusion criteria: 1. male or female aged 2 years to \<13-year-old 2. uncomplicated falciparum malaria as defined as: * positive blood smear with asexual forms of p. falciparum (may be mixed with non-falciparum species) * parasitaemia between 5,000-250,000 parasites/µl * fever defined as tympanic temperature \>37.5°c or history of fever within last 48 hours 3. ability to take oral medication 4. willingness and ability to comply with study protocol for study duration 5. written informed consent given to participate in the trial exclusion criteria: 1. signs of severe/complicated malaria\* 2. any clinical reason suggesting that the child's treatment should be given immediately and not delayed during the transfer to kilifi county hospital in the opinion of the treating physician. 3. acute illness other than malaria requiring urgent systemic treatment as assessed by the treating physician 4. previous splenectomy 5. treatment with artemisinin or act within the previous 7 days 6. treatment with mefloquine in the 2 months prior to presentation 7. known hypersensitivity or contraindication to arterolane-piperaquine, dha-piperaquine, artemisinin, mefloquine (epilepsy, major psychiatric illness) or primaquine 8. qtc interval \>450 milliseconds at point of presentation 9. known personal or family history of cardiac conduction problems 10. participation within another clinical trial in the previous 3 months
short-course antibiotic treatment in aecopd: a meta-analysis of double-blind studies

Conditions: COPD Exacerbation

Summary: chronic obstructive pulmonary disease (copd) is a common disease worldwide and a leading cause of death and disability globally. given that bacteria are implicated in a substantial proportion of acute exacerbation of copd (aecopd), antibiotics are frequently used. however, this current practice may lead to antibiotic overuse further increasing drug resistance and side effects. although the small literature on interventions to prove the effective of short course of antibiotic, a metaanalysis of published randomised double-blind studies comparing the same antibiotics compared to a previous study is performed to determine whether a short course of antibiotic treatment is as effective as a very short course in patients with an exacerbation of copd (eacopd). the authors systematically searched electronic databases on the literature of controlled trials on medline and embase with no language, location, or time restrictions. the authors retrieved observational and controlled trials comparing different durations of the same oral antibiotic therapy in the treatment of acute exacerbations of copd. the authors included 30 randomized, placebo-controlled trials for copd patients. there was no statistically significant difference between shorter and longer antibiotic courses in early clinical success. in conclusion, short-course antibiotic treatment is as effective as very short-course treatment in patients with mild to moderate exacerbations of chronic bronchitis and copd.


Eligibility criteria:
inclusion criteria: * studies considered eligible for inclusion were randomised trials of antibiotic intervention involving adult patients \>18 years of age with a diagnosis of aecopd. exclusion criteria: * studies not published in the english language or with more than two or different antibiotics were excluded

Keywords: aecopd antibiotic treatment meta analysis short course forest plot
an evaluation of blood glucose levels and insulin requirement after subacromial corticosteroid injection in insulin dependent diabetics

Conditions: Shoulder Injury; Insulin-dependent Diabetics

Summary: the overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.


Eligibility criteria:
inclusion criteria * insulin-dependent diabetic * age 18+ * shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs * use of glucometer for blood sugar monitoring * well controlled blood glucose levels * hemoglobin a1c less than or equal to 7.5 exclusion criteria * previous corticosteroid injection within the past 6 months * active infection * pregnant or plan on becoming pregnant * previous adverse event with corticosteroid or lidocaine use
evaluation of modified hyrax versus quad helix in treatment of posterior cross bite

Conditions: Posterior Cross Bite

Summary: this study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition

this study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& quad helix appliances and to compare which one will provide better results in relation to chewing difficulty as a primary outcome of this study and also evaluate the increase in the inter maxillary width , sleep apnea and signs \& symptoms of tempro-mandibular joints disorder in children with posterior cross- bite in mixed dentition cases will be examined within a regular interval up to one year

Eligibility criteria:
inclusion criteria: * children with posterior cross-bite in mixed dentition stage. * children with normal and mild growth pattern. * children with completely erupted upper first molars. exclusion criteria: * children with advanced periodontal diseases. * children having general diseases, syndromes. * children with previous orthodontic. * children with severe horizontal growth patterns.